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Bruker Launches FluoroType® SARS-CoV-2/Flu/RSV PCR Panel in Europe with CE-IVD Mark

December 18, 2020
  • Winter four-plex panel detects clinically most important respiratory viruses SARS-CoV-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)
  • 用鼻咽拭子和口咽拭子进行验证,以获得最高灵敏度
  • 唾液取样选项方便病人,while also achieving high PCR sensitivity; saliva samples do not require extraction and enable a faster, resource-effective workflow

NEHREN, Germany--(BUSINESS WIRE)--Bruker Corporation(纳斯达克:BRKR)今天宣布发射FluoroTypeSARS-CoV-2/Flu/RSVwinter four-plex PCR panel, which enables the sensitive and simultaneous detection of the SARS-CoV-2 virus, of both influenza A and B viruses, as well as of the respiratory syncytial virus (RSV). In the winter season, multiple viruses need to be differentiated in one assay to facilitate diagnosis and patient management.

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Figure 1: FluoroType SARS-CoV-2/Flu/RSV Test Kit (Photo: Business Wire)

Figure 1: FluoroType SARS-CoV-2/Flu/RSV Test Kit (Photo: Business Wire)

TheFluoroTypeSARS-CoV-2/Flu/RSVpanel is CE-IVD labelled according to European IVD Directive (98/79/EC). It has been validated for nasopharyngeal swabs, oropharyngeal swabs and saliva samples. The kit includes all reagents to generate up to 96 PCR result panels in under two hours after nucleic acid extraction. In evaluations, the sensitivity and specificity from 112 nasopharyngeal or oropharyngeal swabs have achieved 100% for all four viruses with very low limits of detection. In addition, the winter four-plex panel has also been validated with an RNA extraction-free protocol on 60 saliva samples with 100% sensitivity and 97.5% specificity. In large scale patient sampling and diagnostic use, sensitivity and specificity near 100% may not always be achievable, but swab and saliva PCR protocols remain the most sensitive assays.

Saliva samples are convenient for patients, e.g. during repeat surveillance or longitudinal testing. Saliva PCR testing is also resource-effective for clinical laboratories in case of extraction kit shortages, and time-to-result is shortened. For optimal performance from saliva, it is recommended not to eat, drink, brush teeth or rinse prior to sampling.

TheFluoroType SARS-CoV-2/Flu/RSV面板可以与布鲁克的高精油一起使用FluoroCycler®XT实时PCR系统,或与其他常见的实时热循环器。它已被验证用于Bruker的GenoxTract®(GXT)automated nucleic acid extraction devices with associated Bruker RNA extraction kits, and for Qiagen extraction chemistry, as well as for the saliva workflow without RNA extraction

德国Suhl的PCR诊断中心(MVZ)的PCR诊断中心(MVZ)的负责人Steffi Czieschnek博士解释说:“多个月来,布鲁克的高质量FluoroType SARS-CoV-2 plusassay was our standard for COVID-19 testing. For the winter season, with an increased incidence of influenza infections, we also needed differentiation of multiple respiratory viruses in one test to avoid additional workload or costs. In an early access program, we have internally validated theFluoroTypeSARS-CoV-2/Flu/RSV面板,我们对这个冬季四重面板的性能感到非常满意,我们现在广泛用于呼吸道疾病样本。”

Dr. Wolfgang Pusch, Executive Vice President Microbiology & Diagnostics at Bruker Daltonics, commented: “We appreciate the positive customer feedback on the performance of our newFluoroTypeSARS-CoV-2/Flu/RSV控制板。与仅检测SARS-COV-2病毒的PCR测定法相比,我们的冬季四重面板可在成本效益的工作流程中增加价值。现在,我们的临床实验室客户还可以选择提供唾液工作流程,以便患者便利,更快的时间和降低资源需求而没有RNA提取。”

About Bruker-Hain Diagnostics

Bruker-Hain Diagnostics专注于Bruker的微生物学和诊断业务中的分子诊断(MDX)产品。Hain Lifescience GmbH也是FluoroCycler® XT,MTBDR 2.0测定,GXT核酸制备试剂盒和FluoroType SARS-CoV-2 plusassays. For more information, please visit,www.hain-lifescience.de.

About Bruker Corporation(Nasdaq: BRKR)

Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology. For more information, please visit:www.fatactor.com.

Investor Contact:
Miroslava Minkova
Director of Investor Relations and Corporate Development
T: +1 (978) 663–3660, ext. 1479
E:Investor.Relations@bruker.com

Contact for Media and Customers:
菲利普·佩里
Bruker Daltonics
T: +49-172-313-7216
E:Philip.Perry@bruker.com

Source: Bruker Corporation

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